ID

31881

Description

Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"; ODM derived from: https://clinicaltrials.gov/show/NCT01030861 Collaborating Parties: National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Center for Research Resources (NCRR) Juvenile Diabetes Research Foundation American Diabetes Association

Link

https://clinicaltrials.gov/show/NCT01030861

Keywords

Versions (1)
  1. 10/7/18 10/7/18 -
Copyright Holder

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Uploaded on

October 7, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Diabetes Type 1 Prevention NCT01030861

English

Eligibility Diabetes Type 1 Prevention NCT01030861

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
between ages of 8-45 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
have a relative with type 1 diabetes
Description

- if first degree relative must be 8-45 years old (brother, sister, parent, offspring) - if second degree relative must be between 8-20 years old (niece, nephew, aunt, uncle, grandchild, cousin)

Data type

boolean

Alias
UMLS CUI [1,1]
C0080103
UMLS CUI [1,2]
C0011854
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C0080103
abnormal glucose tolerance by ogtt confirmed with 7 weeks of baseline visit [fasting blood glucose greater than 110mg/dl or and less than 126 mg/dl or 2 hour glucose greater or equal to 140 mg/dl and less than 200 mg/dl or 30, 60, or 90 minute value on ogtt greater than or equal to 200 mg/dl]
Description

Abnormal glucose tolerance confirmed by ogtt, with fasting blood glucose or 2 hour glucose

Data type

boolean

Alias
UMLS CUI [1,1]
C0235401
UMLS CUI [1,2]
C0029161
UMLS CUI [2,1]
C0235401
UMLS CUI [2,2]
C0428568
UMLS CUI [3,1]
C0235401
UMLS CUI [3,2]
C2238058
presence of at least two confirmed diabetes autoantibodies
Description

Presence of diabetes autoantibodies

Data type

boolean

Alias
UMLS CUI [1,1]
C0004358
UMLS CUI [1,2]
C0011854
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes previously diagnosed or detected at screening [fasting glucose greater or equal to 126 mg/dl or 2 hour glucose greater or equal to 200 mg/dl]
Description

Current type 1 diabetes (fasting glucose, 2 hour glucose)

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C0583513
UMLS CUI [3]
C2238058
abnormalities in blood counts, liver enzymes, inr, positive ppd Test
Description

Abnormalities in blood counts, liver enzymes, inr or positive ppd test

Data type

boolean

Alias
UMLS CUI [1]
C0525032
UMLS CUI [2]
C0041290
UMLS CUI [3]
C0009555
UMLS CUI [4]
C1287351
vaccination with live virus within 6 weeks of randomization
Description

Recent vaccination with live virus

Data type

boolean

Alias
UMLS CUI [1,1]
C1516086
UMLS CUI [1,2]
C0332185
evidence of acute infection based on laboratory testing or clinical evidence
Description

Acute infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0022885
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205210
serological evidence of past current or past hiv , hepatitis b, or hepatitis c infection
Description

Past HIV, Hepatitis B or Hepatitis C infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0036743
UMLS CUI [2,1]
C0019163
UMLS CUI [2,2]
C0036743
UMLS CUI [3,1]
C0019196
UMLS CUI [3,2]
C0036743
be currently pregnant or lactating
Description

Pregnant or lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
prior treatment with study drug
Description

Prior treatment with study drug

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1521826
prior treatment with other monoclonal antibody in past one year
Description

Prior treatment with monoclonal antibody

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0003250
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Similar models

Eligibility Diabetes Type 1 Prevention NCT01030861

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
between ages of 8-45 years
boolean
C0001779 (UMLS CUI [1])
Relatives with Type 1 diabetes between 8-45 years old
Item
have a relative with type 1 diabetes
boolean
C0080103 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2,1])
C0080103 (UMLS CUI [2,2])
Abnormal glucose tolerance confirmed by ogtt, with fasting blood glucose or 2 hour glucose
Item
abnormal glucose tolerance by ogtt confirmed with 7 weeks of baseline visit [fasting blood glucose greater than 110mg/dl or and less than 126 mg/dl or 2 hour glucose greater or equal to 140 mg/dl and less than 200 mg/dl or 30, 60, or 90 minute value on ogtt greater than or equal to 200 mg/dl]
boolean
C0235401 (UMLS CUI [1,1])
C0029161 (UMLS CUI [1,2])
C0235401 (UMLS CUI [2,1])
C0428568 (UMLS CUI [2,2])
C0235401 (UMLS CUI [3,1])
C2238058 (UMLS CUI [3,2])
Presence of diabetes autoantibodies
Item
presence of at least two confirmed diabetes autoantibodies
boolean
C0004358 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Current type 1 diabetes (fasting glucose, 2 hour glucose)
Item
type 1 diabetes previously diagnosed or detected at screening [fasting glucose greater or equal to 126 mg/dl or 2 hour glucose greater or equal to 200 mg/dl]
boolean
C0011854 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0583513 (UMLS CUI [2])
C2238058 (UMLS CUI [3])
Abnormalities in blood counts, liver enzymes, inr or positive ppd test
Item
abnormalities in blood counts, liver enzymes, inr, positive ppd Test
boolean
C0525032 (UMLS CUI [1])
C0041290 (UMLS CUI [2])
C0009555 (UMLS CUI [3])
C1287351 (UMLS CUI [4])
Recent vaccination with live virus
Item
vaccination with live virus within 6 weeks of randomization
boolean
C1516086 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Acute infection
Item
evidence of acute infection based on laboratory testing or clinical evidence
boolean
C0009450 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
Past HIV, Hepatitis B or Hepatitis C infection
Item
serological evidence of past current or past hiv , hepatitis b, or hepatitis c infection
boolean
C0019693 (UMLS CUI [1,1])
C0036743 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2,1])
C0036743 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3,1])
C0036743 (UMLS CUI [3,2])
Pregnant or lactating
Item
be currently pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prior treatment with study drug
Item
prior treatment with study drug
boolean
C1514463 (UMLS CUI [1,1])
C1521826 (UMLS CUI [1,2])
Prior treatment with monoclonal antibody
Item
prior treatment with other monoclonal antibody in past one year
boolean
C1514463 (UMLS CUI [1,1])
C0003250 (UMLS CUI [1,2])
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